# FDA recall Z-0115-2024

> **Access Vascular, Inc** · Class II · device recall initiated 2023-08-31.

## Product

HydroPICC 5Fr Dual Lumen   Maximal Barrier Kit, Product Model Number 80002004

## Reason for recall

Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.

## Distribution

US Nationwide distribution in the states of IL, TX.

## Key facts

- **Recall number:** Z-0115-2024
- **Recalling firm:** Access Vascular, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-31
- **Report date:** 2023-10-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Billerica, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0115-2024

## Citation

> AI Analytics. FDA recall Z-0115-2024. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-0115-2024. Source: US FDA. Licensed CC0.

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